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European Heart Journal Advance Access published online on January 9, 2006
European Heart Journal, doi:10.1093/eurheartj/ehi721
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European Heart Journal © The European Society of Cardiology 2005; all rights reserved
Received December 12, 2005
Revised December 24, 2005
Accepted December 28, 2005

Clinical research

Randomised trial of paclitaxel- and sirolimus-eluting stents in small coronary vessels

Julinda Mehilli 1, Alban Dibra 1, Adnan Kastrati 1 *, Jürgen Pache 1, Josef Dirschinger 2, Albert Schömig 3, and for the Intracoronary Drug-Eluting Stenting to Abrogate Restenosis in Small Arteries (ISAR-SMART 3) Study Investigators

1 Deutsches Herzzentrum, Technische Universität, Lazarettstr. 36, 80636 Munich, Germany
2 Medizinische Klinik rechts der Isar, Technische Universität, Munich, Germany
3 Deutsches Herzzentrum, Technische Universität, Lazarettstr. 36, 80636 Munich, Germany; Medizinische Klinik rechts der Isar, Technische Universität, Munich, Germany

* To whom correspondence should be addressed.
Adnan Kastrati, E-mail: kastrati{at}dhm.mhn.de


  Abstract

Aims Sirolimus- and paclitaxel-eluting stents effectively reduce restenosis in small coronary vessels. The relative efficacy of these drug-eluting stents in this high-risk subset is not known.

Methods and results A total of 360 patients undergoing percutaneous coronary intervention for de novo lesions in native coronary vessels with a diameter of < 2.80 mm received randomly paclitaxel-eluting stents (n = 180) or sirolimus-eluting stents (n = 180). The primary endpoint was in-stent late luminal loss. Secondary endpoints were angiographic restenosis and need of target lesion revascularization. The study intended to show that the paclitaxel-eluting stent is not inferior to the sirolimus-eluting stent with respect to the primary endpoint. The non-inferiority margin was set at 0.16 mm. Follow-up angiography was performed in 87% of the patients. In-stent late luminal loss in the paclitaxel-eluting stent group was 0.32 mm (upper 95% boundary, 0.42 mm), which was greater than that in the sirolimus-eluting stent group, failing to show the non-inferiority of the paclitaxel-eluting stent to the sirolimus-eluting stent (P > 0.99). Angiographic restenosis was found in 19.0% of the lesions in the paclitaxel-eluting stent group and 11.4% of the lesions in the sirolimus-eluting stent group (P = 0.047). Target lesion revascularization was performed in 14.7% of the lesions treated with paclitaxel-eluting stents and 6.6% of the lesions treated with sirolimus-eluting stents (P = 0.008).

Conclusion The paclitaxel-eluting stent is associated with a greater late luminal loss and is less effective in reducing restenosis in small coronary vessels than the sirolimus-eluting stent.

Keywords: Coronary artery disease; Drug-eluting stents; Paclitaxel; Restenosis; Sirolimus.
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